Orocam Recall

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Side Effects & Adverse Reactions

Animals Warnings

For oral use in dogs only.

Due to the pump sizes, dogs weighing less than 5.5 pounds (2.5 kg) cannot be accurately dosed. All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to and periodically during administration of any NSAID. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety) and be given a Client Information Sheet about OroCAM Transmucosal Oral Spray.

Human Warnings

Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans or contact with mucous membranes. Direct contact with skin, eyes, and mucous membranes should be avoided. If contact occurs with skin, the area should be washed immediately with soap and water for at least 20 seconds. In case of contact with eyes, flush immediately with water. Women in late pregnancy should avoid contact with this product.

Animals Warnings

For oral use in dogs only.

Due to the pump sizes, dogs weighing less than 5.5 pounds (2.5 kg) cannot be accurately dosed. All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to and periodically during administration of any NSAID. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety) and be given a Client Information Sheet about OroCAM Transmucosal Oral Spray.

Human Warnings

Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans or contact with mucous membranes. Direct contact with skin, eyes, and mucous membranes should be avoided. If contact occurs with skin, the area should be washed immediately with soap and water for at least 20 seconds. In case of contact with eyes, flush immediately with water. Women in late pregnancy should avoid contact with this product.

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Other Information

Meloxicam belongs to the oxicam class of non-narcotic, non-steroidal anti-inflammatory drugs (NSAID). Each milliliter of OroCAM contains 5 mg meloxicam. Meloxicam is a yellow crystalline powder described chemically as 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide with the following structural formula:

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Abbott Laboratories

Orocam | Abbott Laboratories

Always provide the client information sheet with prescription. Carefully consider the potential benefits and risks of OroCAM and other treatment options before deciding to use OroCAM. Use the lowest effective dose for the shortest duration consistent with individual response. Due to the pump sizes, dogs weighing less than 5.5 pounds (2.5 kg) cannot be accurately dosed. OroCAM should be administered once daily at a dose of 0.1 mg/kg (0.045 mg/lb). See Bottle/Pump Assembly Instructions for Veterinarians and Administration Instructions for Owners.

Particular care should be given with regard to the accuracy of dosing and to selecting the correct bottle size based on the weight of the dog. See the Dosing Table below.

Weight range (kg)

Weight range (lbs)

Bottle Size (mL)/ mg per spray

No. of sprays/ treatment

Dose amount (mg)

2.5 – 3.7

5.5 – 8.3

6 / 0.25

1

0.25

3.8 – 6.2

8.4 – 13.8

6 / 0.25

2

0.50

6.3 – 8.3

13.9 – 18.4

6 / 0.25

3

0.75

8.4 – 12.5

18.5- 27.6

11 / 0.50

2

1

12.6 – 18.8

27.7 – 41.5

11 / 0.50

3

1.50

18.9 – 27.1

41.6 – 59.7

33 / 1.075

2

2.15

27.2 – 40.5

59.8 – 89.1

33 / 1.075

3

3.23

40.6 – 54.0

89.2 – 118.8

33 / 1.075

4

4.3

54.1 – 57.2

118.9 – 125.8

33 / 1.075

5

5.38

Bottle/Pump Assembly Instructions for Veterinarians

Prior to dispensing, the pump should be screwed on to the bottle securely, the bottle gently shaken, and then the pump primed by actuating ten times (or until a fine spray appears) into an absorbent material. Once a bottle is assembled, the assembly date should be written on the bottle and the owner instructed to discard the bottle after 6 months. Wash hands after assembly.

Administration Instructions for Owners

OroCAM should be given according to your veterinarian’s instructions. Prior to each use, shake the bottle gently. If OroCAM is not used for two days or more, owners should re-prime with one spray into an absorbent material, or until a fine spray appears. In case of pump failure, wipe nozzle and then re-prime the pump. If a partial dose has been administered to the pet due to pump failure, do not redose; wait until the next dosing time to adminsiter OroCAM.

To administer OroCAM, grasp the corner of your dog’s mouth and gently pull it away from the gums, opening the cheek space. Place the tip of the applicator just inside the cheek space, directed towards the back of the cheek space. Holding the bottle and pump upright, fully depress the spray head taking special care to ensure no spray escapes from the mouth. If multiple sprays have been prescribed by your veterinarian, allow the pump to fully reflate before administering consecutive sprays. Immediately after administration of the spray, use a moist paper towel or tissue to clean the tip of the pump. Wash hands after administration of the product.

The end of the center tube should be covered by the fluid level. Once the fluid falls below the level of the center tube, sprays will not be adequate and the container should be replaced. There will be a residual volume of fluid at the bottom of the bottle which cannot be used.